Sonlicromanol for post-COVID fatigue with post-exertional malaise.
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
This trial will test whether taking sonlicromanol can reduce fatigue and post-exertional malaise in adults who meet WHO criteria for post-COVID and had a mild initial infection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT07298005 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled phase II trial comparing sonlicromanol to placebo in people with post-COVID who experience post-exertional malaise. Eligible participants meet WHO post-COVID criteria, have PEM by the DSQ-PEM questionnaire, and have a Bell disability score between 20% and 70%, with no prior hospitalization for their acute COVID infection. Participants are randomly assigned to receive sonlicromanol or placebo and outcomes are measured using patient-reported fatigue and PEM instruments and functional disability measures. The trial is led at Amsterdam University Medical Center in the Netherlands and sponsored in collaboration with ZonMw and Khondrion BV.
Who should consider this trial
Good fit: Adults with post-COVID per WHO criteria who report post-exertional malaise on the DSQ-PEM, have a Bell disability score of 20–70%, and whose initial SARS-CoV-2 infection was mild (no hospitalization) are the intended participants.
Not a fit: People with significant cardiac, respiratory, neurological, psychiatric, infectious, or recent cancer conditions, those with extreme BMI, pregnant or breastfeeding individuals, or those with absorption issues or other listed exclusions are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, sonlicromanol could reduce fatigue and improve daily functioning for people with post-COVID post-exertional malaise.
How similar studies have performed: Therapies targeting mitochondrial function including prior sonlicromanol work in mitochondrial disease have shown preliminary signals but using sonlicromanol specifically for post-COVID PEM is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Post COVID according to WHO criteria and verified by post COVID physician * Post-exertional malaise (PEM) according to DSQ-PEM questionnaire * Bell's disability score 20-70% * Mild initial SARS-CoV-2 infection (no hospitalisation) * WHO performance score of 0 before initial SARS-CoV-2 infection Exclusion Criteria: * Patients at risk for cardiac conduction disorders * History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP * Clinically significant respiratory or cardiovascular disease * Unstable neurological disease * Clinically significant active psychiatric disorder that requires treatment * History of substance abuse * Active malignancy within the past 5 years * History of solid organ transplantation * Active HIV, hepatitis B or C infection * BMI \< 18.5 or \> 35 * Pregnancy or breastfeeding * Clinically relevant laboratory test value outside the reference range * Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs) * Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil). * Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives
Where this trial is running
Amsterdam, North Holland
- Amsterdam University Medical Center, Location Academic Medical Center (AMC) — Amsterdam, North Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.